Purdue Pharma settlements a window into U.S. opioid crisis

The DePaulia | October 21, 2019

After more than 2,600 lawsuits nationwide involving their role in the opioid epidemic sweeping through the country, Purdue Pharma — the manufacturer of prescription painkiller OxyContin — filed for bankruptcy Sept. 16. In 2017, opioids were responsible for 47,600 of the 70,237 U.S. drug overdose deaths — with more than 28,000 of these opioid-related deaths being attributed to synthetic opioids, such as fentanyl. From 1999 to 2017, more than 400,000 Americans have died from opioid overdoses. The declaration of bankruptcy followed a tentative $10 to $12 billion settlement with 27 states and thousands of cities and counties throughout the nation — with nearly 20 other states rejecting the terms of the settlement. Dr. Richard Blondell, physician and vice chair for addiction medicine at the Jacobs School of Medicine and Biomedical Sciences at the University at Buffalo, said the company’s heavy marketing downplaying the addictive nature of OxyContin helped start the epidemic. “They promoted this drug heavily,” Blondell said. “I can remember representatives coming around with little bags, pens and clocks. They had a clock that just had 12 on there to remind us to prescribe it every 12 hours. The older physicians said, ‘Boy don’t listen to them. They don’t know what they’re talking about, these are addictive drugs,’ — and it turns out those old, family doctors were right.” Dr. Steven Aks, immersive physician and head of toxicology at Cook County Health, said it’s important to distinguish that there are two “faces” to the current opioid epidemic: pharmaceutical pills and street drugs.

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Everest Medicines Appoints Rogers Yongqing Luo as Chief Executive Officer to Lead Next Stage of Company Growth

Everest Medicines | September 19, 2022

Everest Medicines a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that it has appointed Rogers Yongqing Luo as Chief Executive Officer of the Company, effective immediately. Mr. Luo will also serve as an Executive Director on Everest's Board of Directors. Mr. Luo brings to Everest more than 25 years of experience in the healthcare industry with an extensive leadership track record across clinical development, regulatory affairs and commercialization. Previously, Mr. Luo served as President and General Manager, Greater China at Brii Biosciences and CEO of TSB Therapeutics where he spearheaded the rapid registration approval, GMP certification and successful commercialization of the amubarvimab/romlusevimab combination, the first COVID-19 neutralizing antibody treatment in China. Prior to that, he was Global Vice President and China General Manager at Gilead Sciences where he led the clinical development, regulatory approval and successful commercial launch of eight innovative therapeutics, and efforts that rapidly expanded patient access across China. Mr. Luo previously oversaw the successful launch of several high-profile medicines. He managed sales, marketing, government affairs and market access functions for various leading multinational pharmaceutical companies including Roche and Novartis, and worked two years at Novartis headquarter in Switzerland. "As Everest Medicines continues to evolve our business strategy and expand our novel product pipeline at a rapid pace, we are thrilled to have Rogers join the Company to lead Everest through its next phase of growth in becoming a fully-integrated biopharma company in China. With his robust background as a top executive at both biotech startup and large multinational pharma companies, Rogers brings to Everest a unique set of expertise including comprehensive scientific insight, proven outstanding leadership and excellent commercialization capabilities in patient access, and a demonstrated history of successfully advancing early- and late-stage innovative pipeline to commercial launch in Greater China. In particular, Rogers' leadership will strengthen Everest's new product development and commercial capabilities as we progress toward potential approvals of our late-stage anchor product candidates, including Nefecon, Xerava, etrasimod and mRNA vaccines. We look forward to leveraging Rogers' leadership and industry expertise to generate long-term growth and success across the business." Mr. Wei Fu, Chairman of Everest Medicines and Chief Executive Officer of CBC Group "I'm very excited to join Everest and I look forward to working with this talented, world-class team of scientists and industry professionals to further the Company's industry leadership. We will continue to advance our late-stage pipeline towards commercialization and with our strong balance sheet, we aim to execute synergistic business development deals to accelerate our path to become an integrated biopharma," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "We will continue to invest into our discovery platform to build an innovative therapeutic pipeline for the benefit of patients with unmet needs in Greater China and other Asia Pacific markets, and to create sustained, long-term value for our shareholders." About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases.

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NanOlogy Publishes Review Article of Preclinical and Clinical Research Supporting LSAM-DTX

NanOlogy | September 21, 2022

NanOlogy LLC, a clinical-stage interventional oncology drug company, announced that a review article of preclinical and clinical research supporting its investigational drug, large surface area microparticle docetaxel has been published in Drug Delivery and Translational Research. The review article entitled Local administration of large surface area microparticle docetaxel to solid carcinomas induces direct cytotoxicity and immune‑mediated tumoricidal effects: preclinical and clinical studies provides a review of preclinical research that supports tumor-directed LSAM-DTX as well as promising results from the high-risk nonmuscle invasive bladder cancer arm of a clinical trial of local LSAM-DTX in urothelial carcinoma, which were published earlier this year in The Journal of Urology. The articles also follows an earlier review of preclinical and clinical research supporting another NanOlogy investigational drug, large surface area microparticle paclitaxel published in DDTR in 2020. In addition to LSAM-DTX, NanOlogy clinical programs have advanced tumor-directed LSAM-PTX in pancreas, lung, peritoneal, ovarian, prostate, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts active ingredients into stable large surface area microparticles (LSAMs) of pure drug optimized for tumor-directed therapy and continuous drug release to maximize drug delivered to the tumor and minimize systemic toxicity. Taxane particles are covered by composition of matter patents issued in the US Canada, Europe, Japan, China, Hong Kong, South Korea, Australia, Indonesia, and Russia valid through June 2036. The composition patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, formulations, methods, and technology. About NanOlogy NanOlogy, LLC is a private clinical-stage interventional oncology drug company formed in 2015 to improve the treatment of solid tumors based on a proprietary particle engineering technology platform for tumor-directed drug therapy to maximize drug in tumor and minimize systemic toxicity.

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Ligand Pharmaceuticals Announces Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Ligand Pharmaceuticals | August 02, 2022

Ligand Pharmaceuticals Incorporated announced that effective August 1, 2022, Ligand’s Board of Directors approved the grant of non-qualified stock option awards to purchase an aggregate of 90,073 shares of its common stock, 5,000 restricted stock units and 4,000 performance stock units the target level to six non-executive employees. The options were granted on August 1, 2022, and the grant date for the RSUs and the PSUs will be the date on which Ligand files a Form S-8 Registration Statement to register the shares pursuant to Ligand’s 2022 Employment Inducement Plan. The awards were granted under the Inducement Plan as employment inducement awards pursuant to NASDAQ Listing Rule 5635(c)(4). The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Ligand, or following a bona fide period of non-employment, as an inducement material to such individuals’ entering into employment with Ligand, pursuant to Nasdaq Listing Rule 5635(c)(4). The options have an exercise price of $89.70 per share, which is the closing price of Ligand’s common stock on The Nasdaq Global Select Market on August 1, 2022. The stock options have a term of ten years and will vest over four years, with 12.5% of the shares vesting six months after the employee’s commencement of employment and the balance of the shares vesting in 42 equal monthly installments thereafter, subject to the grantee’s continued service on such vesting dates. The RSUs will vest over three years on the first three anniversaries of the grantee’s commencement of employment, subject to continued service through each applicable vesting date. The PSUs will vest based on the achievement of certain total shareholder return objectives and the completion of the contemplated spin-off of OmniAb, Inc. from Ligand. The number of shares earned under the PSUs may be up to 6,500 in the aggregate if maximum performance levels are achieved. About Ligand Pharmaceuticals Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) ultimately to generate our revenue. Ligand’s OmniAb® technology platform is a patent-protected transgenic animal platform used in the discovery of fully human monoclonal and bispecific therapeutic antibodies. The Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand’s Pelican Expression Technology® is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Gilead Sciences and Baxter International.

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PHARMA TECH

AeroRx Partners with HCmed to Develop a Nebulized LABA/LAMA Combination Solution for the Treatment of Chronic Obstructive Pulmonary Disease

AeroRx Partners | October 03, 2022

AeroRx Therapeutics, LLC. and HCmed Innovations Co., Ltd. have initiated a collaboration, introducing a LABA/LAMA combination solution for delivery with a breath-actuated nebulizer. This collaboration sets forth the framework by which both companies will work together to develop a new nebulized combination formulation for the treatment of chronic obstructive pulmonary disease. According to market reports, it is estimated that there would be close to 34.5 million COPD patients worldwide by 2028, accounting for treatment global sales that could reach up to 19.3 billion USD. AeroRx is currently developing the first nebulized LABA/LAMA combination solution, which could benefit 7-19% of the COPD population. This population group is characterized for suffering from moderate to severe airflow obstruction, which creates difficulties to achieve the inspiratory flow rate required to use most dry powder inhalers optimally. Under this partnership, AeroRx will be responsible for the formulation development, clinical trials, and commercialization of the drug product, while HCmed will be responsible for the customization of the AdheResp breath-actuated nebulizer platform, analyzing and optimizing the formulation's aerosol characterization performance to accommodate the various stages of drug development process and the final combination product. The project will follow a 505(b)2 regulatory pathway, and the corresponding PK/PD study is expected to be conducted with HCmed's nebulizer in 2023. "We are excited to announce our partnership with AeroRx. The AeroRx team has extensive experience in the development of respiratory drugs, while at HCmed we can support our partners to develop drug-nebulizer combination products with our proprietary breath-actuated mesh nebulizer platform. The product of our collaboration will provide COPD patients with an effective inhaled LABA/LAMA combination drug, which will reinforce patients' treatment adherence and improve their quality of life." Jason Cheng, CEO and founder of HCmed Keith Ung, President and co-founder of AeroRx also commented, "We too are enthusiastic about this partnership. Breath-actuated vibrating mesh delivery of inhaled therapeutics is the wave of the future for many therapeutics and HCmed has become one of the leaders in this elegant inhaler device technology." About HCmed Founded in 2014, HCmed Innovations Co., Ltd. is a contract development and manufacturing organization that provides high-quality and cost-effective vibrating mesh nebulizer technology and services to support global pharmaceutical partners in the development of drug-nebulizer combination products for inhalation therapy. HCmed offers a mature customizable mesh nebulizer platform to enhance drug delivery. This technology enables efficient and reliable nebulization of different types of medication, ranging from small molecule synthetics to large molecule biologics, as either solutions, suspensions, or even difficult-to-deliver high viscosity drugs. About AeroRx Founded in 2022, AeroRx Therapeutics, LLC. is a spin-off of iPharma Lab's inhalation CDRO business which was recently acquired by Kindeva Drug Delivery. AeroRx is developing proprietary inhaled products for the treatment of COPD and asthma. The company is led by industry veterans with extensive expertise in inhaled drug delivery and development as well as a track record in building new pharmaceuticals organizations from the ground up.

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